Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma

NCT00398138 | Completed Phase 1 Results

• 4 other identifiers: 06-085P30CA008748P01CA023766MSKCC-06085
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Giving vaccine therapy together with GM-CSF may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy and GM-CSF in treating patients with acute myeloid leukemia, myelodysplastic syndromes, non-small cell lung cancer, or mesothelioma.

Conditions

Leukemia; Lung Cancer; Malignant Mesothelioma; Myelodysplastic Syndromes; Primary Peritoneal Cavity Cancer

Keywords

adult acute myeloid leukemia in remission; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; recurrent non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; advanced malignant mesothelioma; recurrent malignant mesothelioma; primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (2)

• Safety

  Toxicities will be tabulated according to the NCI Common Toxicity (version 3.0).

  2 years

• Immune Response

  Immune reactivity to the peptides will be measured in the same fashion for patients with hematologic or thoracic malignancies. Immune responses will be measured by T cell proliferative response and DTH against WT-1 peptides. In patients with adequate samples, T cell gamma interferon release as measured by ELISPOT will be performed as well.

  2 years

Study Arms (1)

vaccine

EXPERIMENTAL

Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 \& 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 \& -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time \& placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) \& the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response \& have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.

Biological: WT-1 analog peptide vaccine; Biological: incomplete Freund's adjuvant; Biological: sargramostim; Genetic: polymerase chain reaction; Other: flow cytometry; Other: immunoenzyme technique

Interventions

WT-1 analog peptide vaccine BIOLOGICAL

vaccine

incomplete Freund's adjuvant BIOLOGICAL

vaccine

sargramostim BIOLOGICAL

vaccine

polymerase chain reaction GENETIC

vaccine

flow cytometry OTHER

vaccine

immunoenzyme technique OTHER

vaccine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Cytologically or histologically confirmed diagnosis of 1 of the following: * Acute myeloid leukemia, meeting the following criteria: * Documented Wilms tumor-1 (WT-1)-positive disease demonstrated by WT-1 protein on a pretreatment bone marrow biopsy OR detectable disease with real-time quantitative reverse transcriptase-polymerase chain reaction (RQ-PCR) * Completed induction chemotherapy, achieved clinical remission, and completed postremission therapy OR achieved clinical remission and have no plans for further postremission chemotherapy (≥ 65 years of age) * Myelodysplastic syndromes, meeting the following criteria: * Documented WT-1-positive disease demonstrated by WT-1 protein on a pretreatment bone marrow biopsy OR detectable disease by RQ-PCR * International Prognostic Scoring System (IPSS) score of ≥ Int-2 * Not a candidate for cytotoxic chemotherapy * Non-small cell lung cancer, meeting the following criteria: * Positive tumor staining for WT-1 in \> 10% of cells * Stage III or IV disease * Completed chemotherapy, surgery, and/or radiotherapy * Mesothelioma, meeting the following criteria: * Positive tumor staining for WT-1 in \> 10% of cells * Unresectable or relapsed disease * Chemo-naive or received 1 prior chemotherapy regimen * Malignant pleural mesothelioma or peritoneal mesothelioma * No leptomeningeal disease * No CNS involvement PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Absolute neutrophil count ≥ 1,000/mm³ * Platelet count \> 50,000/mm³ (except for myelodysplastic syndromes where parameter is \> 20,000/mm³ and not transfusion dependent) * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal * Creatinine ≤ 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring systemic antibiotics, antiviral, or antifungal treatments * No serious unstable medical illness PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior chemotherapy or radiotherapy * No concurrent systemic corticosteroids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Innovive Pharmaceuticals: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Maslak PG, Dao T, Krug LM, Chanel S, Korontsvit T, Zakhaleva V, Zhang R, Wolchok JD, Yuan J, Pinilla-Ibarz J, Berman E, Weiss M, Jurcic J, Frattini MG, Scheinberg DA. Vaccination with synthetic analog peptides derived from WT1 oncoprotein induces T-cell responses in patients with complete remission from acute myeloid leukemia. Blood. 2010 Jul 15;116(2):171-9. doi: 10.1182/blood-2009-10-250993. Epub 2010 Apr 16.

  PMID: 20400682 RESULT

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia; Lung Neoplasms; Mesothelioma, Malignant; Myelodysplastic Syndromes; Congenital Abnormalities; Carcinoma, Non-Small-Cell Lung

Interventions

incomplete Freund's adjuvant; sargramostim; Polymerase Chain Reaction; Flow Cytometry; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms, Mesothelial; Pleural Neoplasms; Bone Marrow Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques

Results Point of Contact

• Title: Dr. Peter Maslak, Attending
• Organization: Memorial Sloan Kettering Cancer Center

maslakp@mskcc.org

+1212-639-5518

Study Officials

• Lee M. Krug, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 2, 2016
• Results First Posted: March 2, 2016

Record last verified: 2016-02

Locations

US (1)